Evaluation of Synchrony in the Post-operative Patient (SYNCHRONY)

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT01771341

First Posted: January 18, 2013

Last Update Posted: January 22, 2015

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by (Responsible Party):

Hospices Civils de Lyon

Purpose

Neurally adjusted ventilatory support improved synchronization in the medical patient. However no data are available in the postoperative patient.

This way the investigators designed a prospective randomized cross over trial to evaluate this issue in the abdominal post-operative patient.

Condition	Intervention
Patient-ventilator Asynchronism	Device: MAQUET SERVOi ventilator with Edi Catheter Device: MAQUET SERVOi ventilator


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Crossover Assignment Masking: None (Open Label) Primary Purpose: Basic Science
Official Title:	Evaluation of Synchrony in the Post-operative Patient (NAVA vs Pressure Support)

Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:

Asynchrony index (AI) [ Time Frame: 8 hours ]
Number of asynchrony events/total respiratory rate

Secondary Outcome Measures:

PaO2/FiO2 ratio [ Time Frame: 8 hours ]
ratio of partial pressure arterial oxygen and fraction of inspired oxygen


Enrollment:	29
Study Start Date:	February 2012
Study Completion Date:	December 2014
Primary Completion Date:	December 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Pressure support	Device: MAQUET SERVOi ventilator Pressure Support Other Name: Pressure Support
Experimental: NAVA	Device: MAQUET SERVOi ventilator with Edi Catheter NAVA respiratory modality Other Name: Neurally Adjusted Ventilatory Assist

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

adult > 18 yr-old
abdominal post-operative patient
able to trigger the ventilator

Exclusion Criteria:

infant
pregnancy
esophageal surgery
recent esophageal variceal bleeding

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01771341

Locations


France
Hospices Civils de Lyon- Centre Hospitalier Lyon Sud
Pierre Bénite, France, 69310

Sponsors and Collaborators

Hospices Civils de Lyon

Investigators


Principal Investigator:	Florent WALLET, MD	Hospices Civils de Lyon

More Information


Responsible Party:	Hospices Civils de Lyon
ClinicalTrials.gov Identifier:	NCT01771341 History of Changes
Other Study ID Numbers:	2010.646
First Submitted:	June 15, 2012
First Posted:	January 18, 2013
Last Update Posted:	January 22, 2015
Last Verified:	January 2015

Keywords provided by Hospices Civils de Lyon:


NAVA post operative

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